ROUND LAB BIRCH JUICE MOISTURIZING UVLOCK SUNSCREEN SPF45 BROAD SPECTRUM- avobenzone, homosalate, octisalate cream

ROUND LAB BIRCH JUICE MOISTURIZING UVLOCK SUNSCREEN SPF45 BROAD SPECTRUM by

Drug Labeling and Warnings

ROUND LAB BIRCH JUICE MOISTURIZING UVLOCK SUNSCREEN SPF45 BROAD SPECTRUM by is a Otc medication manufactured, distributed, or labeled by SEORIN COMPANY Co., Ltd., Kolmar Korea Co., Ltd . Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Actives Ingredients

Avobenzone 2.7%

Homosalate 13.5%

Octisalate 4.5%

Purpose

Sunscreen

Uses

helps prevent sunburn
if used as directed with other sun protection measures (see Directions) decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

For external use only.

Do not use on damaged or broken skin.

When using this product keep out of eyes. Rinse with water to remove

Stop use and ask a doctor if rash occurs

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• apply liberally and evenly 15 minutes before sun exposure.
• Sun protection measures.

​Spending time in the sun increases your risk of skin cancer and early aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m. - 2 p.m., wear long-sleeved shirts, pants, hats, and sunglasses

• children under 6 months of age: Ask a doctor
• reapply at least every 2 hours.
• use a water-resistant sunscreen if swimming or sweating

Other Information

protect the product from excessive heat and direct sun

Inactive ingredients

Water, Butyloctyl Salicylate, Propanediol, Acrylates Copolymer, Butylene Glycol, Caprylyl Methicone, Polyglyceryl-3 Distearate, Benzotriazolyl Dodecyl P-Cresol, Niacinamide, Diethylhexyl 2,6-Naphthalate, Polymethylsisesquioxane, Glycerin, Calcium Aluminum Borosilicate, 1,2-Hexanediol, Poly C10-30 Alkyl Acrylate, Pentylene Glycol, Cetearyl Aloohol, Tromethamine, Methy propanediol, Glyceryl Stearate Citrate, Betula Platyphylla Japonica Juice, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Carbomer, Ethylhexylglycerin, Artemisia Annua Extract, Anthemis Nobilis Flower Oil, Sodium Stearoyl Glutamate, Glyceryl Polymethacrylate, Triethoxycaprylylsilane, Pinus Sylvestris Leaf Oil, Sparassis Crispa Extract, Polyether-1, Allantoin, Di-propylene Glycol, Glyceryl Glucoside, Biosaccharide Gum-1, Tocopherol, Portulaca Oleracea Extract, Sodium Hyaluronate, Hyaluronic Acid, Ascorbic Acid

Questions or comments?

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PRINCIPAL DISPLAY PANEL

Round Lab

Birch Juice

Moisturizing UVLOCK

Sunscreen

SPF45 Broad Spectrum

50 mL 1.69 fl. oz.

INGREDIENTS AND APPEARANCE

ROUND LAB BIRCH JUICE MOISTURIZING UVLOCK SUNSCREEN SPF45 BROAD SPECTRUM 
avobenzone, homosalate, octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84616-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	13.5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.5 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.7 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BENZOTRIAZOLYL DODECYL P-CRESOL (UNII: 298PX4M11X)
BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)
TROMETHAMINE (UNII: 023C2WHX2V)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)
CHAMAEMELUM NOBILE FLOWER OIL (UNII: UB27587839)
GLYCERYL POLYMETHACRYLATE (300000 MPA.S) (UNII: 2B25A5KAD6)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
PINE NEEDLE OIL (PINUS SYLVESTRIS) (UNII: 5EXL5H740Y)
TOCOPHEROL (UNII: R0ZB2556P8)
HYALURONIC ACID (UNII: S270N0TRQY)
SPARASSIS CRISPA FRUITING BODY (UNII: BOO3RTP9PX)
PURSLANE (UNII: M6S840WXG5)
WATER (UNII: 059QF0KO0R)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
PROPANEDIOL (UNII: 5965N8W85T)
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV)
DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)
NIACINAMIDE (UNII: 25X51I8RD4)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
GLYCERIN (UNII: PDC6A3C0OX)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
BEHENYL ACRYLATE POLYMER (UNII: D64PM5UT4U)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
BETULA PLATYPHYLLA VAR. JAPONICA RESIN (UNII: 1B33PG6N4K)
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) (UNII: 8Z5ZAL5H3V)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ARTEMISIA ANNUA LEAF (UNII: E4M09UY5BL)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
ALLANTOIN (UNII: 344S277G0Z)
GLYCERYL GLUCOSIDE (UNII: 3297VXM8Z6)
ASCORBIC ACID (UNII: PQ6CK8PD0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84616-005-01	50 mL in 1 TUBE; Type 0: Not a Combination Product	09/18/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	09/18/2024

Labeler - SEORIN COMPANY Co., Ltd. (694988081)

Registrant - SEORIN COMPANY Co., Ltd. (694988081)

Establishment
Name	Address	ID/FEI	Business Operations
Kolmar Korea Co., Ltd		963271745	manufacture(84616-005)